ISO 9000: Achieving & Retaining Certification For Professional Services Organizations and Internal Service Departments

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1 ISO 9000: Achieving & Retaining Certification For Professional Services Organizations and Internal Service Departments By Gus Berdebes VP Professional Services, Tenrox March 2003 WHITE PAPER

2 Abstract This white paper reviews ISO 9000, what it provides organizations, and how Tenrox ISO Toolkit helps achieve and retain ISO 9000 certification. We also mention how ISO 9000 relates to Six Sigma, on which white papers are available from Tenrox 1. ISO 9000, coupled with a modern software tool that is capable of facilitating process improvement initiatives and compliance, provides organizations with a remarkable solution that helps meet enterprise-wide ISO 9000 objectives. 1 For a full list of Tenrox White Papers please visit or contact your Tenrox Account Manager. All rights reserved. No part of this document (including, but not limited to, headlines, phrases, concepts, code, methodologies and/or processes) may be reproduced, redistributed, presented, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording, in person, or otherwise, without the prior written permission by Tenrox. Any violation of these rights both domestically or internationally will be pursued and appropriate legal action taken.

3 Table of Contents INTRODUCTION... 1 WHAT IS ISO... 2 ISO 9000 NOT A TRADITIONAL ISO STANDARD... 2 IS GENERIC MANAGEMENT SYSTEM... 3 ISO CERTIFICATION VS. ACCREDITATION... 3 ISO 9000 FAMILY OF STANDARDS... 4 ISO 9000 VS. SIX SIGMA... 5 CAN SMALL COMPANIES BENEFIT FROM ISO?... 6 ISO PROJECT MANAGEMENT STANDARDS... 7 TOOLS TO HELP ACHIEVE AND MAINTAIN ISO TENROX ISO TOOLKIT... 8 IT INFRASTRUCTURE REQUIREMENTS...10 MECHANIZING BUSINESS PROCESSES...11 SIMPLE ISO 9000 WORKFLOW...12 SUMMARY REFERENCES NOTES... 16

4 INTRODUCTION ISO 9000 is an international consensus of good management practices. ISO is an international organization based in Switzerland that is affiliated with hundreds of national standard organizations around the world. The intent of ISO 9000 is to implement predictable, repeatable processes and document their steps so that the products and services meet the customer s requirements, thereby ensuring customer satisfaction. ISO 9000 is a comprehensive, well thought out system that provides an excellent infrastructure for customer satisfaction and efficient operations. At a general level, ISO is similar to other quality initiatives, especially Six Sigma. Six Sigma is briefly reviewed in a later section and Tenrox has published white papers on Six Sigma, which are available upon request. Like many other quality initiatives, ISO 9000 is relevant to all types of organizations, regardless of what the organization does, its size, or whether it is in the private or public sector. The larger and more complicated its processes, the more it will benefit from a quality initiative. ISO 9000 has been implemented in hundreds of thousands of firms worldwide and is increasingly required as a basic condition for doing business with large sophisticated buyers, especially governments. Actually there are three quality assurance models referred to as ISO 9000 : ISO 9001, ISO 9002 and ISO Each one is meant for a particular type of organization, which is explained below. ISO also provides related standards for change management, terminology, management control, statistical techniques, etc. The full list of applicable standards is shown in subsequent sections. ISO 9000 requires documented, repeatable and predictable processes. All organizations implementing or those that have implemented ISO 9000, can benefit from a modern software toolkit that helps optimize, track and analyze business processes. The ability to centralize, automate and track business processes so that they are immediately predictable and repeatable, and automatically auditable, facilitates ISO 9000 certification and compliance. 1

5 What is ISO ISO is the standardized worldwide, multilingual name for the International Organization for Standardization. Located in Geneva, Switzerland 2, the organization s best known standard, ISO 9000, is implemented in over 430,000 organizations around the world. ISO is derived from the Greek word isos which is often used to connote equal or standard. As its name implies, ISO is an international organization 3 made up of over a hundred national standards organizations. The organization consists of members 4 that run the organization and agree to international standards. These national organizations evolved over the last hundred years from engineering, railroad, manufacturing and industrial groups that were interested in standardizing their industries in order to help with interoperability and product sourcing. These groups slowly evolved to become the standard champions within their countries as well as the principle members of ISO. ISO 9000 Not a traditional ISO standard Most ISOs are precise standards that help organizations manufacture consistent, interchangeable products and services. In contrast, ISO 9000, introduced in 1987, is a set of generic standards for business transactions and processes. This family of standards describes what the organization must do to manage the processes so as to improve quality. They describe the essential features of a quality management system. ISO 9000 specifies what requirements your quality system must meet, but does not dictate how they should be met in your organization; such details are assumed to come from the best practices of your particular industry, or your national standards organizations. Since ISO 9000 standards are generic, they apply to all businesses regardless of size or industry. ISO 9000 is a quality management standard that seeks to enhance customer satisfaction by ensuring required steps and processes are followed as specified by the organization, customers, or regulators. It also attempts to facilitate the continual improvement of the products or services being delivered. 2 ISO Central Secretariat, International Organization for Standardization (ISO), Geneva, Switzerland 3 4 There are three types of members: member bodies, correspondent members, and subscriber members. The member bodies represent the voting and active members representing the largest economies. 2

6 IS Generic Management System ISO 9000 was meant to cover the manufacturing as well as the service sector. To be efficient, an organization must ensure that everyone in the organization does his or her job correctly. This is hard to do if the processes and procedures are not formal and documented, if the instructions are not recorded, and if the employees who are supposed to be following the procedures are unaware of their existence, or do not follow them in any case. In this case it would be almost accidental if the customer receives the product or service that was actually ordered. To be efficient, the organization must document and ensure that everyone in the organization does their job and follows the proper procedures to do it. As the organization grows, it becomes more and more difficult to operate without written rules, procedures and processes. ISO Management System standards provide a best practices model for the organization to follow. ISO Certification vs. Accreditation Who is involved in ISO 9000 certification and what is the difference between Certification and Accreditation? Table 6 describes the two basic types of terms that describe ISO 9000 certification. ISO Term ISO 9000 Certification ISO 9000 Accreditation Explanation - ISO 9000 certification usually refers to an organization being assessed against one of the ISO 9000 standards - The certification refers to an attestation that the organization conforms - Certification (sometimes called registration) is handled by certifying bodies, registration bodies or registrars - ISO 9000 accreditation usually refers to organizations that are competent to carry certification that ISO standards are being met 3

7 ISO 9000 Family of standards ISO 9000 is a family of standards that is concerned with quality management. The quality component is defined as delivering what the customer requires. In this context, quality management refers to what the organization does to deliver products that conform to customer requirements. ISO 9000 is actually a number of standards, specifically, ISO 9001, ISO 9002, and ISO 9003, and most certifications refer to meeting one or more of them depending on the type of organization. Organizations choose the appropriate standard for which they wish to be certified. ISO 9001 Design & Development to Servicing ISO 9001 is relevant to organizations whose activities include design, development, production, installation and servicing. ISO 9002 No Design & Development ISO 9002 is relevant to organizations that are not responsible for design and development (for example the customer provides the design and development and the organization does the manufacturing). Otherwise the standard is similar to ISO ISO No controls, only final product testing ISO 9003 is relevant for organizations that do not include controls for design, processes, purchasing and servicing. These organizations use inspections and testing to ensure that their products and services meet customer requirements. ISO 9001, 9002 and 9003 have been integrated into the new ISO 9001:2000 standard 5. To implement ISO 9000 related standards, a number of documents and guidelines are available and recommended by ISO 6. Basically, the guidelines suggest to implement the ISO 9001:2000 for the quality management system of the organization, and later ISO 9004:2000 would be introduced to improve the organization s internal processes: ISO 9000:2000 Quality management systems Fundamentals and vocabulary ISO 9001:2000 Quality management systems Requirements ISO 9004:2000 Quality management systems Guidelines for performance improvements

8 ISO 10006:1997 Quality management Guidelines to quality in project management ISO 10007:1995 Quality management - Guidelines for configuration management ISO :1990 Guidelines for auditing quality systems - Part 1: Auditing ISO :1991 Guidelines for auditing quality systems - Part 2: Qualification criteria for quality systems auditors ISO :1991 Guidelines for auditing quality systems - Part 3: Management of audit programs ISO :1992 Quality assurance requirements for measuring equipment - Part 1: Metrological confirmation system for measuring equipment ISO :1997 Quality assurance for measuring equipment - Part 2: Guidelines for control of measurement processes ISO 10013:1995 Guidelines for developing quality manuals ISO/TR 10014:1998 Guidelines for managing the economics of quality ISO 10015:1999 Quality management Guidelines for training ISO/TR 10017:1999 Guidance on statistical techniques for ISO 9001:1994 Draft International Standards ISO/DIS Measurement control systems ISO/PRF TR Guidelines for quality management system documentation ISO/DIS Guidelines for quality and/or environmental management systems auditing ISO 9000 vs. Six Sigma ISO 9000 is a family of standards that is concerned with delivering what the customer has requested. Reviewing some of its quality management principals below, we can see that there is a similarity between the intent of these two quality systems. ISO 9000 Principles: 1. Customer focus 2. Leadership 3. Involvement of people 4. Process approach 5. System approach to management 6. Continual improvement 7. Factual approach to decision making 8. Mutually beneficial supplier relationships ISO 9000 focuses on ensuring the organization is doing what it says it is doing, that its processes are fully documented, its employees know what the processes are and consistently follow them, and that the organization s processes are predictable and follow industry best practices. Six Sigma focuses on accomplishing the same objectives by using highly trained experts 7 (Master Black Belts, Black Belts and Green Belts). These experts are subject 7 Introduction to Six Sigma, Implementing Six Sigma, Tenrox, G.Berdebes 5

9 matter experts, have statistical analysis training and can design statistical experiments to identify and correct problems. The two could be considered as complementary methodologies. ISO 9000 provides many useful industry best practices documentation and processes for a wide variety of areas, while Six Sigma offers an excellent set of analytical tools and methods to improve these processes and to define best practices. Can Small Companies Benefit from ISO? As we saw above ISO covers thousands of very explicit manufacturing standards, that any business large or small has to follow in order to manufacture and sell the covered products, whether they are screws, resistors, or electronic components. In terms of ISO 9000, which is a general quality management standard, the system aims to document the processes and steps that are followed and then ensure that these steps are actually followed. A one person organization where everything has been memorized and where everything is constantly performed by the same person, may have less need for ISO 9000, than a hundred, or multi-thousand person organization, where new employees are constantly being hired, people are constantly moved around, there are new products or services being introduced, people have to be retrained and their skills updated, customer requirements change etc., and where regulatory and legal demands require the whole organization to perform in a consistent and repeatable manner regardless of these changes. 6

10 ISO Project Management Standards Project management oriented organizations would also be interested in ISO Standards related Project Management: ISO 10006:1997, and software organizations in ISO/IEC TR 16326:1999. Tools to help Achieve and Maintain ISO 9000 ISO 9000 is heavily dependent upon documentation and repeatable procedures. Tenrox ISO Toolkit provides a set of modules that provide the data and process mechanization needed to achieve and retain ISO 9000 certification. Proven, field-tested commercial systems that regulate the consistency of an organization s business processes, can ensure that ISO improvements are captured and enforced by workflow software. These solutions help to institutionalize and mechanize the resulting improvements, which facilitate ISO 9000 certification. Quality improvement methodologies and the analyses that are performed within your organization are only as good as the data on which they are based. That is why it is essential to make sure that your measurement system - your gages, personnel, methods and procedures is stable and capable of measuring your data before continuing with your process improvement efforts. 7

11 Tenrox ISO Toolkit Tenrox ISO Toolkit Web Access Tenrox Enterprise Server Tenrox Software Microsoft Project 2002 Server ISO Home Views & Dashboards Organization Breakdown Structure Work Breakdown Structure Workflow (Business Process) Engine Microsoft Sharepoint Application Server(s) Document Management Security and Audit System Database Server Process Repository Document Repository Tenrox ISO Toolkit provides a complete, modular, scalable and robust quality management/process improvement platform. Tenrox ISO Toolkit not only substantially reduces the cost and time of the process improvement initiative, but it also automates the project and service delivery cycle for professional services organizations (such as consulting, legal and accounting organizations) or internal service departments (such as IT, software or helpdesk departments). 8

12 Tenrox ISO Toolkit has two objectives: 1. Substantially reduce costs and accelerate the implementation of process improvement initiatives 2. Automation of operational processes and administrative overhead, which leads to significant cost reductions, better operational control and visibility and improves the organization s project delivery and service capabilities Tenrox ISO Toolkit automates the entire project and service delivery cycle, from project initiation and budget approval (for internal service departments) or a closed opportunity (for professional services organizations) to scheduling, tracking, scope management, invoicing (charge back), analysis and best practices capture (i.e. maintaining knowledge base articles and FAQs). Tenrox ISO Toolkit automates the quality management initiative by providing: Organization and work breakdown structures: Tenrox manages, displays and reports on the work and organizational breakdown structures as a hierarchy. All tasks, requests, action items and any process or work item is tracked against the organization and work codes. This enables the organization to quantitatively analyze and report on performance, status, results and return of all projects Visual definition of a configurable business process engine: A critical aspect of quality management and process improvement is business process modeling and automation. Tenrox ISO Toolkit includes a visual design tool for all business processes; the toolkit can be used to design the process, add user-defined fields, define event-based notifications, and track all business processes centrally Security and fully audited system activity: Role-based security and audit of all workflow entries provides a secure and powerful reporting and analyzable process data repository Document management: Tenrox ISO provides a powerful and complete Webbased document archival, retrieval, search and check in/check out facility. For more sophisticated features such as document versioning, Tenrox ISO integrates with Microsoft Sharepoint Home views and dashboards: Detailed business process activity information captured is used to create role-based home views and dashboards that include extensive charts and summarized reports; these permit quality managers, project managers and executives to rapidly assess current status and make decisions Integration: Tenrox ISO provides innovative and unique real-time synchronized integration with Microsoft Project. ISO projects and process information are maintained in one enterprise database. Information such as projects, tasks and resources in Tenrox toolkit and Microsoft Project Server is automatically synchronized and updated without any manual import/export 9

13 IT Infrastructure Requirements Sample Organization Network to Support ISO Organization Site 2 WAN Organization Data Center Web Clients Web Clients Application Servers Web Server Web Server Report Server Web-based Project Management, Business Process Management, Document Management and Configuration Management Software and Databases Database and Analysis Server Enterprise Project/Process Database Configuration Management Database As with any quality system, ISO is a very data-driven and data-intensive process improvement framework. The preceding diagram shows a recommended IT, network and software infrastructure to support an ISO initiative. The following information is maintained in each of the above-mentioned databases: Enterprise Project/Process Database: Maintains all project plans, action items, requirements, scope changes, defects, work packages and other process information. The database also maintains a detailed audit of all system and process-related changes and activities. Configuration Management Database: Maintains history, audit and version information on all project documents including specifications, source code, data and other project-related files. 10

14 Note that Tenrox ISO Toolkit is also offered as a hosted solution through Tenrox Hosting services. Hosting reduces up-front IT investments, maintenance costs, and significantly accelerates the time it takes to get a project off the ground. Mechanizing Business Processes The core thrust of ISO 9000 is to document processes, document the steps, and provide adequate training for personnel as to the defined processes, all in the effort to make the processes as dependable and predictable as possible. Doing this is infinitely easier and the whole process becomes more dependable if the processes themselves are mechanized. Recently, easy to use Business Process Management (Workflow) functionality has become readily available. Such a system is useful to all organizations. In the case of industrial organizations pursuing ISO 9000, it can be implemented to ensure their ordering, design, delivery etc. processes are always executed in a perfectly consistent manner; mechanized business processes can easily help enforce this, while automatically creating an audit trail. In the case of service organizations, with their enormous Human Resources related costs, mechanizing business processes that control what most of the people in the organization do, produces even greater benefits. A few examples of project management business processes that must be automated include: project initiation, scope change, staffing request, work package task, defect report, risk assessment and release project. 11

15 Simple ISO 9000 Workflow The diagram that follows shows how business process software helps automate the ISO 9000 process itself. Simple ISO 9000 Workflow 1. Identify the goals 7. Develop plan to close the gaps 2. Identify what others expect 8. Review execution of plan to ensure progress 3. Obtain appropriate ISO info 4. Apply appropriate ISO standards 5. Establish current status, and gaps 6. Determine processes required to deliver products and services to customers 9. Review what ISO compliance is required 10. Schedule external audit if one required 11. Review processes for improvement opportunities 12

16 Simple ISO Workflow 1. Identify the goals 8 Some typical goals may be: - Increase efficiency, reduce costs, reduce waste, increase profitability - Produce products that meet customer requirements - Produce products and services that consistently meet customer requirements 2. Identify what others expect 3. Obtain appropriate ISO info 4. Apply appropriate ISO standards 5. Establish current status, and gaps 6. Determine processes required to deliver products and services to customers 7. Develop plan to close the gaps 8. Review execution of plan to ensure progress 9. Review what ISO compliance is required 10. Schedule external audit if one required 11. Review processes for improvement opportunities - Increase market share What various stakeholders expect: End users, Customers, Employees, Suppliers, Shareholders, Regulators ISO 9000:2000, ISO 9001:2000 and ISO 9004:2000 For example: ISO 9001:2000, ISO for project management, ISO for configuration management, ISO for measurement systems, ISO for quality documentation, ISO/TR for managing the economics of quality, ISO for training, ISO/TS for automotive suppliers, ISO for auditing Can be: Self assessment or assessment by an external organization - ISO 9001: Customer-related processes - Design and/or development - Purchasing - Production and service operations - Control of measuring and monitoring devices ISO 9001:2000 Paragraphs 4.1 and 7.1 provide the information you will need to consider when developing the plan: - Identify the gaps - Identify how to close gaps - Allocate resources - Establish a schedule ISO for information on: - Auditing - Auditor qualification - Managing audit programs Why is ISO being implemented: - Customer s minimum requirement for doing business, for example: General RFP basic submission requirement - General industry norm - Not an industry norm, but main competitor(s) have certification - Regulatory requirement - Internal error reduction initiative Engage an accredited registration/certification body to perform an audit and certify specific system compliance with ISO 9001:2000. ISO 9004:2000 provides a methodology for improvement

17 Summary ISO 9000 is a set of generic standards for business transactions. It specifies what requirements your quality system must meet, but does not dictate how they should be met. Like other quality management systems it attempts to increase customer satisfaction by making the design, creation and delivery of products and services predictable, and in line with what the customer is expecting. Since these standards are generic, they apply to any organization regardless of size or industry. New commercial products such as Tenrox ISO Toolkit help an ISO 9000 initiative in numerous ways to capture, track and analyze all the information related to project delivery and the providing of services. The benefits of such solutions are especially strong when it comes to mechanizing the ISO 9000 related business processes. Using a Web-based workflow, action item, issue, and project tracking software simplifies the task of defining processes and enforcing them without having to track them manually and/or having to provide written guidelines that may not be followed or that may quickly become obsolete. Tenrox offers powerful and award-winning solutions that incorporate sophisticated yet intuitive business process automation functionality. For more information on how Tenrox can help you with your ISO initiative, please contact your Tenrox Account Manager. Gus Berdebes VP Professional Services, Tenrox 14

18 References

19 Notes

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